Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, and effect of ly2405319 after multiple injections in subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study intends to evaluate how safe and well tolerated the ly2405319 compound is when given to people for 7 days (in part 1) and 28 days (in part 2). this study intends to also determine if there is a positive effect on lowering the level of glucose in people with type 2 diabetes.

subjects in part 1 will be randomized to receive ly2405319 or placebo over 7 days in one of 4 dose level groups, in ascending order: 1 mg, 3 mg, 10 mg, or 20 mg. subjects in part 2 will be randomized to receive ly2405319 or placebo over 28 days, and will receive the dose level determined to be the most well tolerated in part 1.

Eligibility criteria:
inclusion criteria: * men and women without child bearing capability * ages 35 to 70 years * type 2 diabetic subjects, diagnosed for at least 3 months * average body weight (relative to height) * willing to be available for the duration of the study exclusion criteria: * significant medical illnesses (except type 2 diabetes) * abnormal 12-lead electrocardiogram (ecg ) * current or previous use of insulin for greater than 7 days for control of diabetes * regular use of drugs of abuse * excessive alcohol use
multicenter cohort study of esd and chemo-radiotherapy for high-risk early-stage esophageal cancer

Conditions: Esophagus Cancer

Summary: this multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection.

our study can further improve the local-regional lymph nodes control rate and alleviate the toxicity of chemoradiotherapy.

Eligibility criteria:
inclusion criteria: * 1. esophageal cancer patients who are pathologically confirmed as pt1a-mm stage or pt1b stage after endoscopic submucosal dissection； 2. no definite contraindications for chemo-radiotherapy； 3. informed consent has been signed； 4. refused surgery after endoscopic submucosal dissection. exclusion criteria: * 1. severe heart, brain, lung disease or renal dysfunction; 2. previous history of other malignancies; 3. prior radiation or chemotherapy 4. researchers consider it inappropriate to participate in this experiment

Keywords: esophagus cancer; radio-chemotherapy; esd
bronchoscopic score for prediction of herpes simplex-virus type 1 (hsv-1) reactivation

Conditions: Tracheobronchitis; Herpes Simplex Infection

Summary: tracheobronchial reactivation of hsv-1 is a common finding in critically ill patients and is associated with longer intensive care unit (icu) stay and mechanical ventilation. at present it is unclear whether the presence of hsv-1 reactivation can be predicted by the clinical phenotype. in the present study, the performance of a bronchoscopic score of tracheobronchial inflammation for prediction of tracheobronchial hsv-1 reactivation is investigated

critically ill adult patients having a first diagnostic or therapeutic bronchoscopy are included. a standardized bronchoscopic score (values from 0 to 6) is assessed by an experienced icu physician. the score compounds are mucosal redness, mucosal swelling and vulnerability on contact. compounds are quantified as "none" = 0, "some, disseminated" = 1, or "profound, ubiquitous" = 2 and added. hsv-1 reactivation is detected by quantitative polymerase chain reaction (pcr) analysis of hsv-1-dna from standardized bronchoalveolar lavage fluid. in addition, hsv-1-dna from blood and markers of immunocompetence (lymphocyte subtype count, monocyte count and human leukocyte antigen - dr isotype (hla-dr) expression, immunoglobulins) are measured for secondary analyses.

Eligibility criteria:
inclusion criteria: * 1. adult patients (age ≥18 years) 2. indication for bronchoscopy during intensive care unit stay 3. written informed consent exclusion criteria: * 1. solid organ transplantation 2. present coronavirus disease 2019 (covid-19) infection 3. previous bronchoscopy during present hospital stay 4. pregnancy 5. known primary or secondary severe immunodeficiency

Keywords: bronchoscopy
a trial comparing the effect of exercise on blood glucose in subjects with type 1 diabetes, who are treated with either insulin degludec or insulin glargine

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of the trial is to compare the effect of exercise on blood glucose in subjects with type 1 diabetes, who are treated with either insulin degludec (ideg) or insulin glargine (iglar).


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index 18.0-27.0 kg/m\^2 (both inclusive) * subjects performing regular physical cardiorespiratory activity * glycosylated haemoglobin (hba1c) below or equal to 9.5 % exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period * supine blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-140 mmhg for systolic or 50-90 mmhg for diastolic
a phase i study to assess the safety and distribution of vb-111 in patients with advanced metastatic cancer

Conditions: Advanced and/or Metastatic Solid Organ Cancer

Summary: aim of the study is to evaluate the safety and find the maximal tolerated dose of vb-111 in patients with advanced metastatic cancer

nine cohorts of dose escalating vb-111 were completed with a total of 56 subjects enrolled.

Eligibility criteria:
inclusion criteria: * patients ≥18 years of age * histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. for cohort 8, malignancy will include only net or rcc. * karnofsky performance status of ≥70% * patients with an adequate hematological profile * patients with an adequate renal function * males and females of childbearing potential must utilize a standard contraception method * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * pregnant or breastfeeding patients * patients, who suffered from an acute cardiac event within the last 12 months * patients with active vascular disease, either myocardial or peripheral * patients with proliferative and/or vascular retinopathy * patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune) * patients with known cns metastatic disease * patients testing positive to one of the following viruses: hiv, hbv or hcv * patients receiving chemotherapy or radiotherapy within the last 4 weeks before enrolment * patients that have undergone major surgery within the last 4 weeks before enrolment * patients may not have received anti-angiogenic therapy within the previous 8 weeks before enrolment. * patients may not have received any other investigational agent within 4 weeks before enrolment. * patients with an ongoing requirement for an immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before enrolment * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
appendicitis during the national lockdown during the covid-19 pandemic

Conditions: Appendicitis

Summary: the study aims to examine whether a nationwide lock-down with an entire population subjugated to social distancing reduces the incidence of appendicitis. if a reduction is detected it supports the hypothesis that infectious disease may play a role in the etiology of appendicitis.


Eligibility criteria:
inclusion criteria: registered in the danish national patient register during the study period exclusion criteria: none

Keywords: covid-19 pandemic incidence
the acute effect of statins on inflammatory markers of athersclerotic tissue

Conditions: Carotid Artery Disease

Summary: this study is being done to determine if the acute administration of the drug simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy


Eligibility criteria:
inclusion criteria: * patients undergoing carotid endarterectomy * no previously known side effects of statins * patients who will sign an informed consent * age \> 18 years old * no signs of current infection exclusion criteria: * patient hypersensitive to any component of this medication * patients with acute liver disease (ast\> normal value) * patients with chronic liver disease (history of hepatitis b or c) * patients with renal failure (creatinine \> 3.0) * patients with unexplained muscle pains and aches * patients with rheumatoid arthritis * patients with lupus * current cancer treatment * patients on cyclosporin, digoxin, itraconazole, ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone * pregnant females
analytical validation of the abioscope device with a psp test: point-of-care precision, sample type comparison and sample stability

Conditions: Sepsis

Summary: abionic sa has developed a novel point-of-care (poc) platform, the abioscope, and an in vitro diagnostic kit for the quantification of the pancreatic stone protein (psp) to be analyzed specifically with the abioscope® device. this test is intended to be used to aid in the early recognition of sepsis. the test is extremely easy to use and has a total turnaround time of approximately 8 minutes. this test uses only 30 microliters of k2/k3-edta anticoagulated whole blood or plasma. results are quantitative (ng/ml). the product is for investigational use only in the us and bears ce-marking. it is commercially available in selected european and non-european countries. the test has also been clinically validated in a multicentric, prospective, observational study performed (ab-psp-001, clinicaltrials.gov identifier nct03474809). the main goals of this study are to evaluate certain analytical performances components of this product in a point-of-care environment, in particular the precision, sample type comparability and specimen stability of the product. such data will support regulatory filing of a us fda 510(k) premarket notification file and of a european ivd regulation technical file to continue product commercialization in 2022, when this novel regulation will be effective.


Eligibility criteria:
inclusion criteria: * provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis * male or female, 18 years of age or older; * hospitalized patient; * covered by a social security scheme. exclusion criteria: * subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure; * subject under juridical protection.

Keywords: in vitro diagnostic device sepsis
long covid symptoms in sars-cov-2-positive children in china

Conditions: Symptoms and Signs

Summary: the goal of this observational study is to learn about in children aged 6-18 years, after the acute phase of sars-cov-2 infection, the covid symptoms or long covid symptoms to impact their daily activities. we aimed to investigate the prevalence of long-lasting symptoms, the duration and intensity of symptoms, quality of life, number of sick days or absences from school, and psychological and social outcomes. the participants will be asked to fill in long covid symptom burden questionnaires who had been infected with sars-cov-2 as self-reported prc test or antigen test positive.

the goal of this observational study is to learn about in children aged 6-18 years, after the acute phase of sars-cov-2 infection, the covid symptoms or long covid symptoms to impact their daily activities. we aimed to investigate the prevalence of long-lasting symptoms, the duration and intensity of symptoms, quality of life, number of sick days or absences from school, and psychological and social outcomes. the participants will be asked to fill in sbq-long covid symptom burden survey questionnaires who had been infected with sars-cov-2 as self-reported prc test or antigen test positive. the survey questionnaires will be filled every two weeks after the participants have been tested sars-cov-2 positive.

Eligibility criteria:
inclusion criteria: infected with sars-cov-2 as self-reported prc test or antigen test positive or have symptoms, but without covid-19 test. exclusion criteria: aged below 6 years or above 18 years
assessing of tooth sensitivity using ibuprofen before in office-tooth bleaching

Conditions: Inflammation; Pulpitis

Summary: ibuprofen has been recognized as anti-inflammatory and analgesic. the purpose of this study is to determine the effect of ibuprofen 400 mg on tooth sensitivity (ts) caused by in-office bleaching. methods: 30 health adults who received either placebo or ibuprofen. the drugs were administered 1 hour prior to the bleaching and will be prescribed 5 doses every 8 hours during 48 hours. for bleaching will be used 35% hydrogen peroxide gel. the tooth sensitivity will be recorded for up and lower arc on two scales: vas (visual analogic scale) and 0-4. the shade evaluation will be performed before and 30 days after bleaching with visual shade guide and spectrophotometer.

background: ibuprofen has been recognized as anti-inflammatory and analgesic. the purpose of this study was to determine the effect of ibuprofen 400 mg on tooth sensitivity (ts) caused by in-office bleaching. methods: a triple-blind, parallel design, randomized clinical trial will be conducted on 30 health adults who received either placebo or ibuprofen. the drugs will be administered 1 hour prior to the bleaching and a every eight hours during 48 hours. for bleaching used 35% hydrogen peroxide gel. the ts will be recorded for up and lower arc on two scales: vas and 0-4. the shade evaluation will be performed before and 30 days after bleaching with visual shade guide and spectrophotometer. the % of patients that reported ts at least once during treatment and the ts intensity will be evaluated by fisher's and mann-whitney tests, respectively. the color changes will be evaluated by repeated measures anova.

Eligibility criteria:
inclusion criteria: * patients included in this clinical trial were: * at least 18 years old. * had good general and oral health. * the participants should have eight caries-free maxillary and jaw anterior teeth and without restorations on the labial surfaces. * the central incisors should be shade c2 or darker. exclusion criteria: * participants that had undergone tooth-whitening procedures. * presenting anterior restorations. * pregnant/lactating. * with severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth). * taking any kind of medicine, bruxism habits or any other pathology that could cause sensitivity (such as recession, dentine exposure). * participants that reported some earlier or present health problems in stomach, heart, kidney and liver, or participants using any continuous drug with anti-inflammatory and antioxidant action were excluded from the study.

Keywords: analgesics ibuprofen inflammation tooth bleaching
efficacy and safety study of brinzolamide 1%/brimonidine 0.2% vs. brinzolamide 1% and brimonidine 0.2%

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study was to evaluate the efficacy and safety of a fixed combination of brinzolamide/brimonidine in lowering intraocular pressure (iop) relative to each of its individual active components in patients with open-angle glaucoma and/or ocular hypertension.

this study consisted of 6 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 3 on-therapy visits conducted at week 2, week 6, and month 3. a washout period based on previous ocular medication preceded eligibility visit 1. patients who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1:1) to receive treatment with 1 of 3 study drugs for 3 months. study drug instillation began the morning after the second eligibility visit.

Eligibility criteria:
inclusion criteria: * sign informed consent document. * diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s. * other protocol-specified inclusion criteria may apply. exclusion criteria: * females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures. * any form of glaucoma other than open-angle glaucoma. * severe central vision loss in either eye. * chronic, recurrent, or severe inflammatory eye disease. * ocular trauma within the preceding 6 months. * ocular infection or ocular inflammation within the preceding 3 months. * clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment. * best-corrected visual acuity score worse than 55 letters using the early treatment diabetic retinopathy study chart. * other ocular pathology (including severe dry eye) that may, in the opinion of the investigator, preclude the administration of study product. * ocular surgery within the preceding 6 months. * ocular laser surgery within the preceding 3 months. * any abnormality preventing reliable applanation tonometry. * any other conditions, including severe illness, which could make the patient, in the opinion of the investigator, unsuitable for the study. * other protocol-specified exclusion criteria may apply.

Keywords: aog oht open-angle glaucoma ocular hypertension
gut microbiomes in patients with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: metabolic syndrome (ms) is defined by a manifestation of cardiometabolic risk factors including high blood pressure, glucose and triglycerides, low high-density lipoprotein (hdl) cholesterol, and abdominal obesity. it is closely associated with other diseases such as fatty liver and gouty arthritis. in recent years there is evidence that gut microorganisms are intimately linked to health and wellbeing. here, the investigators hypothesize that gut microorganisms are involved in the regulation and/or onset of ms and its symptoms.

there is mounting evidence that the gut microbiome plays a vital role in health and wellbeing. in particular, population-association and mouse model studies have demonstrated that gut bacteria can be reproducibly linked to obesity and diabetes. there is, however, a lack of progress in translating current scientific knowledge to healthcare practices in part due to the strong influence of biogeography and demography on gut microbiomes. another major knowledge gap in gut microbiomes is the ecology of gut viruses and their associations with ms despite having intimate relationships with human and bacterial hosts. in this study, the investigators aim to assess variation in the gut microbiomes of patients with ms with reference to the healthy population in hong kong, and to explore gut microorganisms as predictive/diagnostic markers of ms and clinical outcomes associated with medical interventions. this will be achieved through studying microorganisms in the stools of participants. the investigators will use the 16s small subunit ribosomal rna (16s rrna) marker gene to create compositional profiles of the gut microbial community in healthy and individuals with ms to identify bacterial populations that are associated with the onset and progression of ms. a subset of samples will be selected for bulk dna sequencing based on their stool community profiles and/or ms parameters to obtain genomic information of the microorganisms involved. participants who undergo intervention as part of their routine medical care for ms will be invited to provide stool samples following intervention. these stools will be used to profile gut microbial communities to investigate whether their compositions undergo changes reflective of medical intervention. here, the aim is to investigate whether resolution of ms symptoms can be linked to alterations in gut microorganisms, and the hypothesis is that their profiles will more closely resemble healthy individuals following medical intervention.

Eligibility criteria:
inclusion criteria: * resident of hong kong exclusion criteria: * major organ system impairment such as heart failure, renal failure, and severe impairment of respiratory function. * on long-term regular immunosuppressive therapy * current or history of malignancy * current or history of major gastrointestinal diseases, including inflammatory bowel disease, major gastrointestinal surgery * on medication for glucose or lipid control, such as metformin and statin

Keywords: gut microbiome stool
pregabalin versus placebo in the treatment of neuropathic pain associated with hiv neuropathy

Conditions: Neuropathy

Summary: the purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with hiv neuropathy.

based on dmc interim efficacy analysis results indicating a low probability for success the study was terminated on april 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

Eligibility criteria:
inclusion criteria: * men and women, ages of 18 or greater * documented evidence of hiv-1 infection * documented diagnosis of hiv-associated distal symmetrical polyneuropathy (dsp) with subjective sensory symptom of pain * pain starts in the feet exclusion criteria: * subject has untreated vitamin b12 deficiency (serum b12 level \<200 pg/ml) or if treated b12 deficiency -treatment is less than 6 months of b12 supplementation (injection or intranasal b12) prior to screening * diabetes mellitus requiring regular medical treatment (other than diet and exercise) or hba1c \>6.9 * subjects with peripheral neuropathic pain that is not associated with hiv infection; including subjects with conditions such as: post herpetic neuralgia (phn), diabetic peripheral neuropathy (dpn), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy

Keywords: neuropathy pain hiv-1 hiv infections
acute and chronic pulmonary and renal complications following contracting severe respiratory distress syndrome coronavirus-19

Conditions: Pulmonary and Renal State

Summary: tracking post- corona virus infection pulmonary and renal complications

mortality from pulmonary and renal system is highly noticable with covid-19 pandemic . we trying to monitor compliction

Eligibility criteria:
inclusion criteria: * all covid 19 patients admitted to icu exclusion criteria: * refusal to participate